Determining insulin dosing schedules and carbohydrate-to-insulin ratios in diabetic patients

• US 9,872,890 B2
• Filed: 03/19/2004
• Issued: 01/23/2018
• Est. Priority Date: 03/19/2003
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Harry R. Hebblewhite, Paul C. Davidson
• Inventors: Davidson, Paul C., Hebblewhite, Harry R.
• Primary Examiner(s): Whaley, Pablo S
• Application Number:
  US10/804,825
• Publication Number:
  US 20050049179A1
• Time in Patent Office: 5,058 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Method for digitally determining the daily insulin regimen for a diabetic patient. The invention divides the patient'"'"'s day into adjustable time intervals containing basal insulin dosage rates and Carbohydrate-to-Insulin Ratio(s) (for determining meal insulin doses). The invention identifies the Corrective Insulin doses over a time interval as an “error” in the Prescription Insulin (Basal Insulin+Meal Insulin). Methods involve first estimating the change to one of these two components of Prescription Insulin, and then determining the change to the other by subtracting from the error. One method estimates Change in Meal Insulin distributed among intervals proportional to old Meal Insulin. Another method lumps After-Meal Corrective Insulin together with Meal Insulin. Another method splits the interval at the After-Meal Corrective Dose and determines Basal from Time-Boundary Corrective Dose. Data may be obtained from the previous day, and a small fraction of error applied, leading to asymptotic reduction of error. Data may be obtained from recent history, and a larger fraction of error applied by doctor or automatic method.

Claims

1. A computer-implemented method of dynamically adjusting an insulin dosing scheme of a subject in an insulin pump, comprising:

obtaining, by at least one computing device implemented in the insulin pump and comprising at least one hardware processor, data comprising a previous insulin dosing scheme of the subject and blood glucose data of the subject relating to the previous insulin dosing scheme; and

determining, by the at least one computing device, an adjusted insulin dosing scheme for the subject based on the data and the previous insulin dosing scheme, the adjusted insulin dosing scheme comprising;

(a) combining, by the at least one computing device, a base insulin dosage administered over a given previous time interval (Basal Insulin) with an additional insulin dosage administered in relation to a meal taken during the previous given time interval (Meal Insulin) to determine a previous total insulin prescribed for the given time interval (Prescription Insulin);

(b) determining, by the at least one computing device, an error in the previous total insulin prescribed by determining a difference between previous blood glucose data and a blood glucose target, dividing the difference by a Correction Factor (CF), applying a fraction of the divided difference to determine the error, and applying a portion of said error to Meal Insulin and a portion of the error to Basal Insulin, by either;

(i);

determining, by the at least one computing device, a preliminary desired change to Meal Insulin as an independent variable and then determining a change to Basal Insulin as a dependent variable, wherein the change to Basal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin, or

(ii);

determining, by the at least one computing device, a preliminary desired change Basil Insulin as an independent variable and then determining a change to Meal Insulin as a dependent variable, wherein the change to Meal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin; and

(c) determining, by the at least one computing device, a change to a Carbohydrate-to-Insulin Ratio (CIR) to be used in adjusting the insulin dosing scheme to arrive at an adjusted insulin dosing scheme either by;

(i) multiplying, by the at least one computing device, the change to Meal Insulin by a rate of change of the Carbohydrate-to-Insulin Ratio (CIR) with respect to Meal Insulin, which is determined as a calculus derivative of a population-based correlation, or

(ii) determining, by the at least one computing device, a change for the Carbohydrate-to-Insulin Ratio (CIR) for a 24 hour period based on a combination of a total Meal Insulin for the 24 hour period plus the error in the previous total insulin prescribed for the 24 hour period minus a change for Basal Insulin for the 24 hour period, and dividing a total amount of carbohydrates for the 24 hour period by the combination; and

causing, by the at least one computing device, the adjusted insulin dosing scheme determined for the subject to be shown in a display of an insulin device comprising the insulin pump for an implementation of the adjusted insulin dosing scheme; and

administering, by the insulin device, at least a portion of the insulin to the subject in accordance with the adjusted insulin dosing scheme.

2. The computer-implemented method of claim 1, wherein the adjusted insulin scheme is comprised of one or more adjusted values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).

3. The computer-implemented method of claim 1, further comprising rendering, by the at least one computing device, the adjusted insulin dosing scheme in a video screen, generating, by the at least one computing device, a printed report, generating, by the at least one computing device, a digital file, or communicating, by the at least one computing device, the adjusted insulin dosing scheme to an operating program of the insulin pump.

7. The computer-implemented method of claim 1, wherein the change to Carbohydrate-to-Insulin Ratio of step(c)(i) is determined as the rate of change of CIR with respect to a total insulin dose for a 24 hour period times the rate of change of the total insulin dose for the 24 hour period with respect to Meal Insulin for the 24 hour period.

14. The computer-implemented method of claim 1, wherein the previous insulin dosing scheme is comprised of one or more values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).

4. An insulin pump configured to dynamically adjust an insulin dosing scheme of a subject, comprising:

an insulin cartridge comprising insulin;

an infusion set configured to provide the insulin from the insulin cartridge into the subject through a cannula;

a battery;

at least one computing device comprising at least one hardware processor; and

program instructions executable in the at least one computing device that, when executed, cause the at least one computing device to determine a rate at which insulin is introduced into the subject by;

accessing data comprising a previous insulin dosing scheme of the subject and blood glucose data of the subject relating to the previous insulin dosing scheme; and

determining an adjusted insulin dosing scheme for the subject based on the data, the adjusted insulin dosing scheme comprising;

(a) combining a base insulin dosage administered over a previous given time interval (Basal Insulin) with an additional insulin dosage administered in relation to a meal taken during the previous given time interval (Meal Insulin) to determine a previous total insulin prescribed for the given time interval (Prescription Insulin),

(b) determining an error in the previous total insulin prescribed by determining a difference between previous blood glucose data and a blood glucose target, dividing the difference by a Correction Factor (CF),

applying a fraction of the divided difference to determine the error, and applying a portion of the error to Meal Insulin and a portion of the error to Basal Insulin, by either of two methods of;

(i) determining a preliminary desired change to Meal Insulin as an independent variable and then determining a change to Basal Insulin as a dependent variable, wherein the change to Basal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin, or

(ii);

determining a preliminary desired change to Basil Insulin as an independent variable and then determining a change to Meal Insulin as a dependent variable, wherein the change to Meal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin; and

(c) determining a change to a Carbohydrate-to-Insulin Ratio (CIR) to be used in adjusting the insulin dosing scheme to arrive at an adjusted insulin dosing scheme either by;

(i) multiplying the change to Meal Insulin by a rate of change of the Carbohydrate-to-Insulin Ratio (CIR) with respect to Meal Insulin, which is determined as a calculus derivative of a population-based correlation, or

(ii) determining a change for the Carbohydrate-to-Insulin Ratio (CIR) for a 24 hour period based on a combination of a total Meal Insulin for the 24 hour period plus the error in the previous total insulin prescribed for the 24 hour period minus a change for Basal Insulin for the 24 hour period, and dividing a total amount of carbohydrates for the 24 hour period by the combination; and

providing, via the infusion set, at least a portion of the insulin to the subject in accordance with the adjusted insulin dosing scheme determined for the subject.

5. The insulin pump of claim 4, wherein the adjusted insulin scheme is comprised of one or more adjusted values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).

6. The insulin pump of claim 4, further comprising program instructions that, when executed, cause the at least one computing device to render the adjusted insulin dosing scheme in a video screen of an electronic display, generate a printed report, generate a digital file, or communicate the adjusted insulin dosing scheme to an operating program of the insulin pump.

8. The insulin pump of claim 4, wherein the change to Carbohydrate-to-Insulin Ratio of step(c)(i) is determined as the rate of change of CIR with respect to a total insulin dose for a 24 hour period times the rate of change of the total insulin dose for the 24 hour period with respect to Meal Insulin for the 24 hour period.

15. The insulin pump of claim 4, wherein the previous insulin dosing scheme is comprised of one or more values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).

9. A system, comprising:

at least one computing device comprising at least one hardware processor;

an insulin device comprising a display and an insulin pump; and

an application executable in the at least one computing device that, when executed, causes the at least one computing device to;

access data comprising a previous insulin dosing scheme of a subject and blood glucose data of the subject relating to the previous dosing scheme; and

determine an adjusted insulin dosing scheme for the subject based on an analysis of the data performed by the at least one computing device, the adjusted insulin dosing scheme comprising;

(a) combining a base insulin dosage administered over a previous given time interval (Basal Insulin) with an additional insulin dosage administered in relation to a meal taken during the previous given time interval (Meal Insulin) to determine a previous total insulin prescribed for the given time interval (Prescription Insulin),

(b) determining an error in the previous total insulin prescribed by determining a difference between previous blood glucose data and a blood glucose target, dividing the difference by a Correction Factor (CF), applying a fraction of the divided difference to determine the error, and applying a portion of the error to Meal Insulin and a portion of the error to Basal Insulin, by either;

(i) determining a preliminary desired change to Meal Insulin as an independent variable and then determining a change to Basal Insulin as a dependent variable, wherein the change to Basal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin, or

(ii);

determining a preliminary desired change to Basil Insulin as an independent variable and then determining a change to Meal Insulin as a dependent variable, wherein the change to Meal Insulin is calculated as the error in the previous total insulin prescribed less the preliminary desired change to Meal Insulin; and

(c) determining a change to a Carbohydrate-to-Insulin Ratio (CIR) to be used in determining the adjusted insulin dosing scheme either by;

(i) multiplying the change to Meal Insulin by a rate of change of the Carbohydrate-to-Insulin Ratio (CIR) with respect to Meal Insulin, which is determined as a calculus derivative of a population-based correlation, or

(ii) determining a change for the Carbohydrate-to-Insulin Ratio (CIR) for a 24 hour period based on a combination of a total Meal Insulin for the 24 hour period plus the error in the previous total insulin prescribed for the 24 hour period minus a change for Basal Insulin for the 24 hour period, and dividing a total amount of carbohydrates for the 24 hour period by the combination; and

causing, by the at least one computing device, the adjusted insulin dosing scheme determined for the subject to be shown in the display of the insulin device for an implementation of the adjusted insulin dosing scheme; and

administering, by the insulin device, at least a portion of the insulin to the subject in accordance with the adjusted insulin dosing scheme determined for the subject.

10. The system of claim 9, wherein the adjusted insulin scheme is comprised of one or more adjusted values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).

11. The system of claim 9, wherein causing the insulin pump to provide at least the portion of the insulin to the subject in accordance with the adjusted insulin dosing scheme further comprises causing the insulin device to pump the insulin from an insulin cartridge into the subject through a cannula.

12. The system of claim 9, wherein the application, when executed, further causes the at least one computing device to render the adjusted insulin dosing scheme in a video screen, generate a printed report, generate a digital file, or communicate the adjusted insulin dosing scheme to an operating program of the insulin pump.

13. The system of claim 9, wherein the change to Carbohydrate-to-Insulin Ratio of step(c)(i) is determined as the rate of change of CIR with respect to a total insulin dose for a 24 hour period times the rate of change of the total insulin dose for the 24 hour period with respect to Meal Insulin for the 24 hour period.

16. The system of claim 9, wherein the previous insulin dosing scheme is comprised of one or more values for a daily schedule of Basal Rates, a daily schedule of Carbohydrate-to-Insulin Ratios, a daily schedule of Meal Insulin doses, or one or more values of Correction Factor (CF).